Composition:
Each film coated tablet contains:
Aceclofenac BP 100 mg
List of Excipients:
Lactose
Maize Starch
Microcrystalline Cellulose
Povidone K30
Colloidal Anhydrous Silica
Purified Talc
Magnesium Stearate
Hypromellose E15
Titanium Dioxide
Iron Oxide of Yellow
Other Excipients ---- q.s
Pharmacodynamic Properties:
Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties.
The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis.
Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.
Pediatric Data:
Not recommended for use in children under 18 years of age.
Pharmacokinetic Properties:
After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug.
The volume of distribution is approximately 25 L.
The mean plasma elimination half-life is around 4 hours.
Aceclofenac is highly protein-bound (>99%).
Approximately two-thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites.
Therapeutic Indications:
Aceclofenac is indicated for the relief of pain and inflammation in:
Osteoarthritis
Rheumatoid arthritis
Ankylosing spondylitis
Dosage and Administration
The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening or as directed by physician.
Mode of Administration:
Oral
Possible Side Effects:
Nausea
Vomiting
Diarrhoea
Flatulence
Constipation
Dyspepsia
Abdominal pain
Melaena
Haematemesis
Ulcerative stomatitis
Exacerbation of colitis
Crohn's disease
Drug - Drug and Food Interaction:
Other analgesics including cyclooxygenase-2 selective inhibitors:
Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects.
Anti-hypertensives:
NSAIDs may reduce the effect of anti-hypertensives.
The risk of acute renal insufficient, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when ACE-inhibitors or angiotensin II receptor antagonists are combined with NSAIDs.
Contraindication:
Hypersensitivity to Aceclofenac or to any of the excipients.
Contraindicated in patients who have Asthma, rhinitis, angioedema or urticaria in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
Patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Warnings and Precautions for Use:
The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as:
Oral corticosteroids
Anticoagulants such as warfarin
Selective serotonin-reuptake inhibitors
Antiplatelet agents such as aspirin
Caution:
Aceclofenac should also be administered with caution and under close medical surveillance to patients with congestive heart failure, significant risk factors for cardiovascular events and history of cerebrovascular bleeding.
Pregnancy and Lactation:
Not recommended for pregnant women and breast feeding mothers.
Overdose:
Symptoms
Include:
Headache
Nausea
Vomiting
Epigastric pain
Gastrointestinal irritation
Gastrointestinal bleeding
Rarely diarrhoea
Disorientation
Excitation
Coma
Drowsiness
Dizziness
Tinnitus
Hypotension
Respiratory depression
Fainting
Occasionally convulsions
In cases of significant poisoning acute renal failure and liver damage are possible.
Treatment
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered.
Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.
Storage Condition:
Store below 30°C.
Protect from light & moisture.
Presentation:
Zulu®-100:
Blister Pack of 10's
30's
100's
1000's
Manufactured by:
ATOZ Pharmaceuticals Pvt. Ltd.
No.12, Balaji Nagar,
Ambattur,
Chennai - 600 053.
INDIA.
Marketed by:
OA&J Pharmaceuticals Ltd.
Plot No. IND/A/71/G/11,
Tema Heavy Indl. Area,
GHANA.